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American Academy of Ozonotherapy Guidelines for Ozone Generators Used in Medicine, Dentistry, and Veterinary Medicine 


Philosophy On Ozone Generating Equipment
It is the wish of the American Academy of Ozonotherapy to provide guidance to its members while still complying with applicable law. It is the domain of regulators to establish standards for devices used in medicine, dentistry, and veterinary medicine. It is the responsibility of manufacturers to meet or exceed those standards. In the absence of such regulatory standards in the United States, many questionable ozone generating devices populate the marketplace and each individual user is left to determine which devices are both safe and effective to use in medicine, dentistry, and veterinary medicine. The Academy is concerned that regulatory standards have not been promulgated in the United States for ozone generators for use in medicine, dentistry, and veterinary medicine. Thus, some ozone generating equipment used in medicine, dentistry, and/or veterinary medicine in the United States may be unsafe and/or ineffective. Accordingly, the Academy encourages its members to review the international guidelines referenced below. These are guidelines, not standards. The Academy aspires to set the bar that one day may inspire regulators to shape the law of the land.


Choosing And Using Ozone Generating Equipment 
The primary mission of the Academy is educational and investigative. In the absence of applicable regulatory standards it is important that Academy members avoid questionable devices. The Academy encourages its members, in choosing ozone generating equipment, to consider the international reference guidelines cited here and to request manufactures to provide written manufacturing specifications for purposes of evaluating compliance with the international reference guidelines. It is, however, always the responsibility of each and every user to form his or her own decision concerning what equipment to use and to be diligent, vigilant, and responsible in its use. Generation, control, and administration of ozone gas for any medical use is the responsibility of the treating healthcare practitioner. It is important to use equipment and methods demonstrated through scientific principles and research, good manufacturing practices, and clinical experience to be both safe and effective.


            The Academy encourages all its members to insure in writing from the manufacturer of any ozone generator you are considering using for medical purposes that either the generator bears a European CE2B certification, or that it meets the following guidelines:
a) The generator is certified by an independent testing body for Electrical, Quality, Fire Safety and Proof of Professional Manufacturing and Quality by having one of these certifications: ETL, CSA, UL, QAI, or TUV. 
b) The generator electrode must be constructed from either quartz glass, Hastelloy C, or 316 stainless steel.
c) Any and all internal and external parts that come into contact with ozone including electrodes, tubes, and connectors must be made of quartz glass, Hastelloy C, 316 stainless steel, Kynar, Halar, Teflon, polyether ether ketone (PEEK), fluorosilicone, fluoroelastomer FPM (VITON), fluoroelastomer FKM, perfluoroelastomer KPFE (KALREZ), or polychlorotrifluoroethylene PCTFE (Kel-F).  No other materials should be used.  Silicone may be used externally only.
d) The generator must be constructed to be used with pure oxygen as the input gas.  Generators that are designed to be used with room air cannot be safely used with pure oxygen.
e) The generator must come with a calibration chart indicating what the concentration of the ozone is at various settings.  The manufacturer must guarantee that the final concentration is within 10% ± of what is indicated on the calibration chart.
f) The generator must come with a destructor unit that prevents any ozone from escaping into the room air.  Destructor units convert ozone back to O2.
g) The generator should come with a syringe port because there will some applications that require the ability to fill a syringe with ozone.
h) The generator must come with a regulator that it has been calibrated to.


References:
Guidelines and Recommendations for Medical Professionals Planning to Acquire a Medical Ozone Generator, approved on July 11, 2014 by International Scientific Community of Ozone Therapy ISCO3. 
Madrid Declaration on Ozone Therapy, ISCO3, 2nd ed., 2015, pg 11. 
J.A. Roth and Sullivan D.E., Ind. Eng. Chem. Fundam. 1981, 20, 137-140. 
Installation and method for laboratory ozone experiments at low dose: International Ozone Association Guideline: 50010 A Date: 04/22/2012 Rev: 1
Materials and ozone compatibility guidelines: International Ozone Association Guideline. 30010A Date: 04/22/2013
Sleeper and Henry, “Durability Test Results of Construction and Process Materials Exposed to Liquid and Gas Phase Ozone”, Ozone: Science & Engineering, 24:249-260 (2002).

Disclaimer
The Academy does not recommend, endorse, approve, certify, or warrant any particular ozone generating device as safe or effective or as suitable for any purpose. The Academy does not undertake to monitor or assure safety or quality of any particular ozone generating device. 

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